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NCT03984825 · ClinicalTrials.gov registry record · Phase 1
Effect of GSK3640254 on the Pharmacokinetics of a Combination Oral Contraceptive
A Phase 1 study, sponsored by ViiV Healthcare.
- Completed
- Registry status
- Phase 1
- Development phase
- 23
- Enrollment target
NCT03984825: Completed Phase 1 study, sponsored by ViiV Healthcare.
NCT03984825 is a Phase 1 study that has completed, run by ViiV Healthcare. The registered enrollment target is 23 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03984825, a Phase 1 study, has completed, sponsored by ViiV Healthcare.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 23 participants
- Enrollment target
Study Summary
This is an open-label, single-sequence, 1-way drug-drug interaction study to investigate the effect of GSK3640254 on the pharmacokinetics of a combination oral contraceptive containing ethinyl estradiol (EE) and levonorgestrel (LNG). Effective contraception for women infected with human immunodeficiency virus (HIV) is important in the prevention of unplanned pregnancies. The study will consist of a screening period of 28 days, check-in (Day -4), a run-in period and a treatment period. During the run-in period, subjects will be administered Portia® (0.03 milligrams \[mg\] EE/0.15 mg LNG) once daily on Days -3 to -1. Subjects will then be administered Portia once daily on Days 1 to 10 of treatment period A followed by administration of Portia once daily along with GSK3640254 200 mg on Days 11 to 21 of treatment period B. The duration of the study is approximately 8 weeks, including Screening and Run-in. Portia is a registered trademark of Teva Pharmaceuticals USA.
Primary Outcome
Blood samples were collected at indicated time points for the analysis of AUC (0-tau) of EE. PK parameters were calculated by standard non-compartmental analysis. The PK population included all participants who underwent plasma PK sampling and had evaluable PK parameters estimated.
Interventions
- DRUG GSK3640254
- DRUG Portia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2019-06-13 |
| Est. Completion | 2019-08-16 |
| Phase | Phase 1 |
What the finished NCT03984825 record still lists
NCT03984825 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 2 interventions - of which GSK3640254 is the first listed.
NCT03984825 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03984825 about?
NCT03984825 is a clinical study titled "Effect of GSK3640254 on the Pharmacokinetics of a Combination Oral Contraceptive". This is an open-label, single-sequence, 1-way drug-drug interaction study to investigate the effect of GSK3640254 on the pharmacokinetics of a combination oral contraceptive containing ethinyl estradiol (EE) and levonorgestrel (LNG). Effective contraception for women infected with human immunodefici...
What is the current status of trial NCT03984825?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 23 participants. The study started on 2019-06-13. Estimated completion is 2019-08-16.
What interventions are being tested in trial NCT03984825?
The interventions under investigation include: GSK3640254 (DRUG), Portia (DRUG).
Who is sponsoring clinical trial NCT03984825?
This trial is sponsored by ViiV Healthcare, which has 182 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03984825's enrollment target sits among peer trials
23 1596th of 2000 higher than 400 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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